ISO 9001 3rd Party Audit Preparation - Open Issues Aspects

[potdar]

There are plenty of good auditors, registrars, companies, Quality Managers that prowl this board. If you are not happy with what you have, then make whatever changes are needed or possible. That is our jobs. We are the Change Agents for our companies and clients.

If it were easy, then everyone would be doing it! But, it is worth pursuing.

Agreed again. We still consider it worth pursuing. And thats why we are still here discussing it.

I also offer a common modern day situation to consider: A company is offering a product in the market. The customers are happy with the offering. Regular repeat orders keep flowing in. Quality is improving by the day. Turnover, profits are improving by the day. Employees are getting richer salaries and better benefits. The management is keenly involved in the day to day running and in the progress plans of the Company. The Company has a good working system and is SUCCESSFUL.

The recertification audit for ISO 9001 is due. The MR, like Angie, is running from pillar to post not knowing where is what. No internal audits were ever done in time. CAs are lying open.PA / CI records dont exist. Other documentation is hopelessly outdated. Management reviews are having fake records. A massive exercise is launched to 'prepare' for the audit. People work for day and night and somehow get through the audit. Then they go to sleep for another year. Nobody gives it a second thought. This is routine. ISO is bullxxxx.

The problem is that the management never believed in or wanted a certificate. They were forced into it by their customer. They wanted a paper on the wall, hired a consultant. He knew nothing of the intricasies of their operation. He brought a generic system and declared it as installed. He also brought in an auditor who declared it as certified. (mind you, this also is routine.) And then, the yearly 'preparations' for the audit started. They have now become the norm.

The company has an excellent working system, but it is nowhere close to what is described in their QMS documentation. Only an insider can possibly change it - difficult as the management doesnt believe. A third party 'good' auditor can at most write a bunch of NCs, or refuse certification. A consultant cant intervene unless invited.

We talk of being change agents. Maybe, we do manage to bring in small changes in our small spheres of activity. But imagine a great banner CB going to audit a great banner global manufacturing / service company and refusing / withdrawing certification or even any AB refusing / withdrawing accreditation from a great banner CB. Those sort of change agents will hopefully be born. They are not around yet.

Still, lets keep pursuing and discussing!

 

[Helmut Jilling]

Agreed again. We still consider it worth pursuing. And thats why we are still here discussing it.

I also offer a common modern day situation to consider: A company is offering a product in the market. The customers are happy with the offering. Regular repeat orders keep flowing in. Quality is improving by the day. Turnover, profits are improving by the day. Employees are getting richer salaries and better benefits. The management is keenly involved in the day to day running and in the progress plans of the Company. The Company has a good working system and is SUCCESSFUL.

The recertification audit for ISO 9001 is due. The MR, like Angie, is running from pillar to post not knowing where is what. No internal audits were ever done in time. CAs are lying open.PA / CI records dont exist. Other documentation is hopelessly outdated. Management reviews are having fake records. A massive exercise is launched to 'prepare' for the audit. People work for day and night and somehow get through the audit. Then they go to sleep for another year. Nobody gives it a second thought. This is routine. ISO is bullxxxx.

The problem is that the management never believed in or wanted a certificate. They were forced into it by their customer. They wanted a paper on the wall, hired a consultant. He knew nothing of the intricasies of their operation. He brought a generic system and declared it as installed. He also brought in an auditor who declared it as certified. (mind you, this also is routine.) And then, the yearly 'preparations' for the audit started. They have now become the norm.

The company has an excellent working system, but it is nowhere close to what is described in their QMS documentation. Only an insider can possibly change it - difficult as the management doesnt believe. A third party 'good' auditor can at most write a bunch of NCs, or refuse certification. A consultant cant intervene unless invited.

We talk of being change agents. Maybe, we do manage to bring in small changes in our small spheres of activity. But imagine a great banner CB going to audit a great banner global manufacturing / service company and refusing / withdrawing certification or even any AB refusing / withdrawing accreditation from a great banner CB. Those sort of change agents will hopefully be born. They are not around yet.

Still, lets keep pursuing and discussing!

I think there is a fundamental flaw in your statement. Your paragraphs discuss that the company has an excellent working system. The rest of your paragraphs discuss a dysfunctional working system.

I have seen many companies like that. They put in a system, but it is NOT a good working system. However, the company functions inspite of the system!

The problem is we confused currently making a profit with a good system. "Currently making a profit" can quickly change when a competitor get some traction with their working system. They get more robust. The pace of improvement at the competitor increases, and over time the competitor overtakes the company. Then, they begin to realize their system was not effective and blame the Quality Manager.

If you have an ineffective management system or quality system, eventually it will catch up with you.

Have we not all seen examples of this? GM and Ford vs Toyota is certainly not the only example of this.

 

[potdar]

I think there is a fundamental flaw in your statement. Your paragraphs discuss that the company has an excellent working system. The rest of your paragraphs discuss a dysfunctional working system.

I have seen many companies like that. They put in a system, but it is NOT a good working system. However, the company functions inspite of the system!

The problem is we confused currently making a profit with a good system. "Currently making a profit" can quickly change when a competitor get some traction with their working system. They get more robust. The pace of improvement at the competitor increases, and over time the competitor overtakes the company. Then, they begin to realize their system was not effective and blame the Quality Manager.

If you have an ineffective management system or quality system, eventually it will catch up with you.

Have we not all seen examples of this? GM and Ford vs Toyota is certainly not the only example of this.

Sorry. No agreement this time.

I have given you an example where the working system is alive and kicking, it is effective and it is rigidly followed. The management is extracting all benefits of working systematically.

The problem is not with the working system. It is the mismatch between the working system and the documented system. Actually it is the documented system which is a load of crap. But unfortunately, for the auditor it is the Bible. He can only look through his blinkers and say 'You dont do what is written here.' So, NC.

Let the management take the auditor's words and start following the documented systems, and all that you have described about competition taking over.. will happen.

By the way, TOYOTA never believed in ISO or QS. They are still reluctant to consider TS. Ford and GM have been having well documented working systems for ages - since much before everyone else dreamt about it.

 

[Helmut Jilling]

Sorry. No agreement this time.

I have given you an example where the working system is alive and kicking, it is effective and it is rigidly followed. The management is extracting all benefits of working systematically.

In over a 1000 audits, I have never seen a situation where "the working system is alive and kicking, it is effective and it is rigidly followed," but yet is a total mismatch to the documented system. I don't think even a sleeping consultant could implement something that would be that disconnected. Perhaps that is so, but my nose tells me otherwise.

How do we determine the "working system is alive and kicking, it is effective and it is rigidly followed?" Usually because we are currently still making money, but have not yet realized that the foundation is already crumbling. This thread began with a discussion of a system not firing on all cylinders. Usually, management does not know the unseen degradation taking hold until it is obvious. The system metrics, done correctly, however, will demonstrate the condition earlier, if they are used. Sort of an SPC of the management processes if you will.

The problem is not with the working system. It is the mismatch between the working system and the documented system. Actually it is the documented system which is a load of crap. But unfortunately, for the auditor it is the Bible. He can only look through his blinkers and say 'You dont do what is written here.' So, NC.

Here, I will pretty much agree with you. They agreed to work to the illsuited system, and they aren't.

Let the management take the auditor's words and start following the documented systems, and all that you have described about competition taking over.. will happen.

By the way, TOYOTA never believed in ISO or QS. They are still reluctant to consider TS. Ford and GM have been having well documented working systems for ages - since much before everyone else dreamt about it.

It is true they don't require it, but most of their suppliers are certified to one version or the other. They are not opposed to it. Also, they don't implement it themselves, but their reasons were simply that they already had a system (very similar in concepts to ISO), so why should they abandon it and start over with an equivalent program. Especially one based on the far more ridgid structure of the earlier version.

My brother is CEO of a manufacturing firm that is not ISO certified, but in a walk through his system, he's 80-90% there because he has applied the same, common sense principles of modern manufacturing management that is built into ISO and the Toyota systems. He would have to line up the ISO shalls and such, but the structure is very similar. It is also not that far different than the principles I applied years ago in a small company I ran.

Quality and world class do not just happen. You have to work your system, and most companies still leave much on the table.

 

[Wes Bucey]

As many know, I have often weighed in on "registration versus compliance" and often commented that the customer is the real "tail that wags the dog" about registrars and registrants who have conspired (consciously or unconsciously) to put an unmerited certificate on the wall and responsibility for breaking the vicious cycle lies squarely in the lap of the customer who mandates every supplier in his supply chain be registered to the Standard without really understanding that registration does not now, nor ever has guaranteed a conforming product with on time delivery and no "hiccups" in the relationship between customer and supplier.

Talking to registrars and registrants without the customer's power and authority over the purse is an empty exercise akin to two drunks in a saloon arguing over a government's foreign policy.

 

[potdar]

In over a 1000 audits, I have never seen a situation where "the working system is alive and kicking, it is effective and it is rigidly followed," but yet is a total mismatch to the documented system.

Well, I have.

How do we determine the "working system is alive and kicking, it is effective and it is rigidly followed?" Usually because we are currently still making money, but have not yet realized that the foundation is already crumbling. This thread began with a discussion of a system not firing on all cylinders. Usually, management does not know the unseen degradation taking hold until it is obvious. The system metrics, done correctly, however, will demonstrate the condition earlier, if they are used. Sort of an SPC of the management processes if you will.

Hmm.. a well documented, properly evaluated system...

It is true they don't require it, but most of their suppliers are certified to one version or the other. They are not opposed to it. Also, they don't implement it themselves, but their reasons were simply that they already had a system (very similar in concepts to ISO), so why should they abandon it and start over with an equivalent program. Especially one based on the far more ridgid structure of the earlier version.

My brother is CEO of a manufacturing firm that is not ISO certified, but in a walk through his system, he's 80-90% there because he has applied the same, common sense principles of modern manufacturing management that is built into ISO and the Toyota systems. He would have to line up the ISO shalls and such, but the structure is very similar. It is also not that far different than the principles I applied years ago in a small company I ran.

Quality and world class do not just happen. You have to work your system, and most companies still leave much on the table.

How do we determine the "working system is alive and kicking, it is effective and it is rigidly followed?" Is it because they are currently still making money?

Talking to registrars and registrants without the customer's power and authority over the purse is an empty exercise akin to two drunks in a saloon arguing over a government's foreign policy.

In most cases I have described, the customer is also unfortunately hand in glove with the registrant and the registrar. I could list for you bulk deals done by parties wanting to do TS with registrars and consultants to get their suppliers certified to ISO. The CSR is 'Do not audit them for ISO. This a copy of our green book. Just see that they follow it.'

So, I would rather put this as a discussion between two drunks in a local saloon regarding the condition of the potholed roads made by corrupt contractors for the corrupt municipality run by corrupt politicians elected by the foolish drunks.

But yes, the drunks are concerned as their cars use the roads. So they should pursue changes and discuss.

 

[navalbhawsar]

during a third party audit of a packaged drinking water plant, validation clause was excluded with a reason that no special process is involved which can not be measured. Whether the exclusion was right?

 

[Helmut Jilling]

during a third party audit of a packaged drinking water plant, validation clause was excluded with a reason that no special process is involved which can not be measured. Whether the exclusion was right?

I'm not clear clear what kind of special processes a water plant would have. Most tests you would perform would be normal lab tests for biological purity, etc.

 

[AndyN]

during a third party audit of a packaged drinking water plant, validation clause was excluded with a reason that no special process is involved which can not be measured. Whether the exclusion was right?

You may wish to post this as a new item, instead of adding it on to a (very old) thread........

BTW it's not the duty of the 3rd party to exclude anything!

 

[navalbhawsar]

Sorry for including in very old thread! However thanks for reply. In my opinion, clause 7.5.2 should not be excluded for want of validation of results in drinking water plant as concern of customer to food and drink safety is utmost.